Regulatory affairs

Courses from other providers

• Clinical Development and NDA submission in Japan
  Emne: Regulatory affairs, Japan, Procedures / Rutines, Management, Clinical trials, International regulation
  Udbyder: ECCRT
  Sted: Brussels, Belgium
  Dato: 14 September 2010
  
• Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
  Emne: Regulatory affairs, Market, Finance, Lifecycle management, Strategy
  Udbyder: CfPIE
  Sted: King of Prussia, PA, USA
  Dato: 15-16 September 2010
  
• Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
  Emne: Regulatory affairs, Devices, CE labelling, EU regulation, ISO
  Udbyder: CfPIE
  Sted: 1) Malvern, PA, USA 2) Dublin, Ireland
  Dato: 1) 15-16 September 2) 11-12 October 2010
  
• Medical Information: Information or Promotion?
  Emne: Regulatory affairs, Market, Advertising, Strategy
  Udbyder: ACRP
  Sted: Internet
  Dato: 22 September 2010
  
• Patent and Other Intellectual Property Law for the Life Sciences Industry
  Emne: Regulatory affairs, Market, Interlectual property rights
  Udbyder: CfPIE
  Sted: King of Prussia, PA, USA
  Dato: 22 September 2010
  
• Purchasing Controls in the Medical Device Industry
  Emne: Regulatory affairs, Devices, Regulatory management, QA
  Udbyder: CfPIE
  Sted: Costa Mesa, CA, USA
  Dato: 22-23 September 2010
  
• The EU Clinical Trial Directive
  Emne: Regulatory affairs, Clinical trials, EU regulation, Europe, CTD
  Udbyder: CfPIE
  Sted: King of Prussia, PA, USA
  Dato: 28-29 September 2010
  
• Regulatory Compliance in UK Laboratories Processing Clinical Trial Samples: Guidance from a UK Regulatory Inspector
  Emne: Regulatory affairs, Europe, Procedures / Rutines
  Udbyder: ACRP
  Sted: Internet
  Dato: 29 September 2010
  
• European Filing & Registration Procedures
  Emne: Regulatory affairs, Europe, Registration file, Registration procedures
  Udbyder: CfPIE
  Sted: 1) King of Prussia, PA, USA 2) Dublin, Ireland
  Dato: 1) 30 September - 1 October 2) 7-8 October 2010
  
• Compliance for Biopharmaceutical API Process Validation
  Emne: Regulatory affairs, Europe, Biotech, Regulation, USA, FDA
  Udbyder: Key2Compliance
  Sted: Copenhagen, Denmark
  Dato: October 2010
  
• Medical Device CE Marking - The Latest Requirements
  Emne: Regulatory affairs, Devices, CE labelling
  Udbyder: David Begg Associates
  Sted: Cork, Ireland
  Dato: 4 October 2010
  
• Pharmaceutical Law & Administration
  Emne: Regulatory affairs, Europe, EMEA, ICH, Ph.Eur., Procedures / Rutines, Registration procedures, Maintenance, EU regulation, US regulation, USA, FDA, Procedures / Rutines
  Udbyder: David Begg Associates
  Sted: York, England
  Dato: 4 October 2010
  
• The Challenge of Developing a Regulatory Intelligence Network to Support Global Clinical Trials: Communication & Collaboration
  Emne: Regulatory affairs, Clinical trials, International regulation, EU regulation
  Udbyder: RAPS
  Sted: Internet
  Dato: 6 October 2010
  
• Coordinating a Clinical Trial
  Emne: Regulatory affairs, Clinical trials, International regulation, Development
  Udbyder: Medical Research Management
  Sted: Coral Springs, FL, USA
  Dato: 7-8 October 2010
  
• Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
  Emne: Regulatory affairs, Devices, Product lifecycle, Market, Advertising, Maintenance, Lifecycle management
  Udbyder: CfPIE
  Sted: King of Prussia, PA, USA
  Dato: 12-13 October 2010
  
• Supplier Evaluation, Qualification and Control for Medical Devices
  Emne: Regulatory affairs, Devices, CE labelling, Development, International regulation, Regulatory management
  Udbyder: David Begg Associates
  Sted: Manchester, England
  Dato: 12 October 2010
  
• Understanding the European Directives & Implementing the Guidelines
  Emne: Regulatory affairs, Clinical trials, EU regulation, Clinical development, Clinical trials, EU regulation
  Udbyder: ECCRT
  Sted: Brussels, Belgium
  Dato: 1) 13 October 2) 20 December 2010
  
• Crisis Management: Focus on Pharmaceutical Product Crisis
  Emne: Regulatory affairs, Maintenance, Crisis management
  Udbyder: DIA
  Sted: Paris, France
  Dato: 14.15 October 2010
  
• Human Factors for Medical Devices
  Emne: Regulatory affairs, Devices, International regulation
  Udbyder: AAMI
  Sted: Minneapolis, MN, USA
  Dato: 18-20 October 2010
  
• The Art of Writing a Clinical Overview - 3-part Online Training Series
  Emne: Regulatory affairs, Documentation, CTD-format, Clinical trials, International regulation
  Udbyder: DIA
  Sted: Internet
  Dato: 19-21 October 2010
  
• Preparing the Chemistry and Pharmacy Section of the EU Registration Dossier
  Emne: Regulatory affairs, Europe, CTD, Registration file, Registration procedures
  Udbyder: IIR PTI
  Sted: London, England
  Dato: 19-21 October 2010
  
• Analytical Methods Validation for FDA Compliance
  Emne: Regulatory affairs, USA, FDA
  Udbyder: CfPA
  Sted: Amsterdam, The Netherlands
  Dato: 25-27 October 2010
  
• How to Perform Effective Product Quality Reviews
  Emne: Regulatory affairs, Documentation, API, EU regulation
  Udbyder: David Begg Associates
  Sted: Manchester, England
  Dato: 26 October 2010
  
• Pharmaceutical Legislation Update
  Emne: Regulatory affairs, Europe, EMEA, QA, QP, Maintenance, EU regulation
  Udbyder: David Begg Associates
  Sted: Manchester, England
  Dato: 27 October 2010
  
• CMC Submissions in CTD Format
  Emne: Regulatory affairs, Documentation, CMC, CTD-format, Europe, CTD, USA, CTD
  Udbyder: CfPA
  Sted: Amsterdam, The Netherlands
  Dato: 4-5 November 2010
  
• Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
  Emne: Regulatory affairs, USA, Management, FDA, Procedures / Rutines
  Udbyder: CfPIE
  Sted: Berlin, Germany
  Dato: 4-5 November 2010
  
• Preparing IND Submissions
  Emne: Regulatory affairs, USA, CTD, FDA, Procedures / Rutines
  Udbyder: Barnett International
  Sted: San Diego, CA, USA
  Dato: 15-16 November 2010
  
• Latin America – Understanding Regulatory Compliance Requirements
  Emne: Regulatory affairs, Latin America, Procedures / Rutines, Registration
  Udbyder: CfPIE
  Sted: King of Prussia, PA, USA
  Dato: 15-16 November 2010
  
• Regulatory Affairs for Biotechnology
  Emne: Regulatory affairs, Biotech, Development, Regulation
  Udbyder: IIR PTI
  Sted: London, England
  Dato: 18-19 November 2010
  
• Quality Aspects of the CTD
  Emne: Regulatory affairs, Documentation, CTD-format, Europe, CTD
  Udbyder: David Begg Associates
  Sted: York, England
  Dato: 22 November 2010
  
• Mastering EU Requirements for Product Labelling & Package Leaflets
  Emne: Regulatory affairs, Product information, PIL, Labelling, EU regulation
  Udbyder: IIR PTI
  Sted: London, England
  Dato: 24-26 November 2010
  
• 2nd Joint DIA/ European Medicines Agency Innovation Forum: Is the EU Regulatory Framework Ready?
  Emne: Regulatory affairs, Europe, Procedures / Rutines
  Udbyder: DIA
  Sted: London, England
  Dato: 29-30 November 2010
  
• Regulatory Affairs for Clinical Trials
  Emne: Regulatory affairs, Clinical trials, International regulation, Children, Development, Application, EU regulation
  Udbyder: IIR PTI
  Sted: Basel, Switzerland
  Dato: 29-30 November
  
• Clinical Trial Design For Medical Devices
  Emne: Regulatory affairs, Devices, Clinical trials
  Udbyder: CfPIE
  Sted: Costa Mesa, CA, USA
  Dato: 2-3 December 2010
  
• Radiation Sterilization for Medical Devices
  Emne: Regulatory affairs, Devices, International regulation
  Udbyder: AAMI
  Sted: Arizona, Phoenix, USA
  Dato: 7-10 December 2010
  
• Drug Approval Process
  Emne: Regulatory affairs, USA, CTD, FDA
  Udbyder: Barnett International
  Sted: San Diego, CA, USA
  Dato: 9-10 December 2010
  
• Drug Development & FDA Regulations
  Emne: Regulatory affairs, USA, FDA
  Udbyder: Barnett International
  Sted: Philadelphia, PA, USA
  Dato: 9-10 December 2010
  
• Medical Device Good Clinical Practice & Monitoring
  Emne: Regulatory affairs, Devices, GCP, Regulatory management, EU regulation, International regulation, ISO
  Udbyder: Medical Research Management
  Sted: Coral Springs, FL, USA
  Dato: 9-10 December 2010
  
• ICH-Q7
  Emne: Regulatory affairs, Europe, ICH
  Udbyder: CfPA
  Sted: Amsterdam, The Netherlands
  Dato: 13-15 December 2010
  
• Global Registration and Approval Process
  Emne: Regulatory affairs, Procedures/Rutines, China, Procedures / rutines, Europe, CTD, Registration file, Registration procedures, Procedures / Rutines, USA, CTD, Procedures / Rutines
  Udbyder: ECPM
  Sted: Basel, Switzerland
  Dato: 7-10 February 2011
  
• Integrated Product Development, Portfolio Management and Marketing
  Emne: Regulatory affairs, Market, Product development, Lifecycle management, Advertising, Strategy
  Udbyder: ECPM
  Sted: Basel, Switzerland
  Dato: 27-30 June 2011
  
• History of US Drug Regulation
  Emne: Regulatory affairs, USA, FDA
  Udbyder: DIA
  Sted: Internet
  Dato: Ongoing
  
• CT10: The IND: How to gain approval for clinical trials in the USA
  Emne: Regulatory affairs, Clinical trials, Application, International regulation, Clinical development, Clinical trials, International regulation, Regulation
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Good Clinical Practices (GCPs)
  Emne: Regulatory affairs, Clinical trials, International regulation
  Udbyder: RAPS
  Sted: Internet
  Dato: Ongoing
  
• SUB11: The Decentralised Procedure (DCP)
  Emne: Regulatory affairs, Europe, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Electronic Common Technical Document (eCTD)
  Emne: Regulatory affairs, Japan, CTD, Europe, CTD, Registration file, USA, CTD
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Essentials of EU and US Regulatory Affairs for Human Products
  Emne: Regulatory affairs, Europe, Registration procedures, Procedures / Rutines, USA, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• EU Variation Procedure
  Emne: Regulatory affairs, Maintenance, Variations, EU regulation
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Orphan Drug Applications in the EU and USA
  Emne: Regulatory affairs, Europe, Orphan drugs, USA, Orphan drugs, Procedures / Rutines, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Preparing Submission in the Common Technical Document (CTD) Format
  Emne: Regulatory affairs, Europe, Registration file, Japan, USA, CTD, Procedures / Rutines, Procedures / Rutines, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• Registration of Monoclonal Antibodies
  Emne: Regulatory affairs, Biotech, Regulation, Europe, USA, Procedures / Rutines, Antibodies, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• SUB08: The ANDA: Requirements for obtaining FDA approval for a generic product in the USA
  Emne: Regulatory affairs, USA, Procedures / Rutines, CTD
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• SUB09: The NDA process: Requirements for obtaining approval for a new drug in the USA
  Emne: Regulatory affairs, USA, Procedures / Rutines
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• The European Centralised Procedure (CP)
  Emne: Regulatory affairs, Europe, Registration procedures
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing
  
• The Mutual Recognition Procedure (MRP)
  Emne: Regulatory affairs, Europe, Registration procedures
  Udbyder: Zenosis
  Sted: Internet
  Dato: Ongoing